Stronger together: a cross-SIG perspective on improving drug development

Luke Fostvedt^{1

2}, Jiawei Zhou^{3

4}, Anna G Kondic^{5

6}, Ioannis P Androulakis^{5

7}, Tongli Zhang^{8

9}, Meghan Pryor^{5

10}, Luning Zhuang^{11

6}, Jeroen Elassaiss-Schaap^{8

12}, Phyllis Chan^{13

14}, Helen Moore^{8

15}, Sean N Avedissian^{11

16}, Jeremy Tigh^{11

17}, Kosalaram Goteti^{13

18}, Neelima Thanneer^{19

6}, Jing Su^{19

20}, Sihem Ait-Oudhia²⁰

Affiliations

¹ ISoP, Statistics and Pharmacometrics SIG, NJ, Bridgewater, USA. luke.fostvedt@pfizer.com.
² Pharmacometrics and Systems Pharmacology, Pfizer Inc, Groton, CT, USA. luke.fostvedt@pfizer.com.
³ ISoP, Mathematical and Computational Sciences SIG, NJ, Bridgewater, USA. jiawei.zhou@pfizer.com.
⁴ Pharmacometrics and Systems Pharmacology, Pfizer Inc, Groton, CT, USA. jiawei.zhou@pfizer.com.
⁵ ISoP, Quantitative Systems Pharmacology SIG, NJ, Bridgewater, USA.
⁶ Clinical Pharmacology and Pharmacometrics, Bristol-Myers Squibb, Princeton, NJ, USA.
⁷ Biomedical Engineering Department, Rutgers University, Piscataway, NJ, USA.
⁸ ISoP, Mathematical and Computational Sciences SIG, NJ, Bridgewater, USA.
⁹ Department of Pharmacology and Systems Physiology, College of Medicine, University of Cincinnati, Cincinnati, OH, USA.
¹⁰ Translational PKPD, Johnson & Johnson Innovative Medicine, Spring House, PA, USA.
¹¹ ISoP, Clinical Pharmacometrics SIG, NJ, Bridgewater, USA.
¹² PD-value B.V, Utrecht, Netherlands.
¹³ ISoP, Statistics and Pharmacometrics SIG, NJ, Bridgewater, USA.
¹⁴ Clinical Pharmacology Modeling & Simulation, Genentech, South San Francisco, CA, USA.
¹⁵ Laboratory for Systems Medicine, College of Medicine, University of Florida, Gainesville, FL, USA.
¹⁶ Antiviral Pharmacology Laboratory, College of Pharmacy, University of Nebraska Medical Center, Omaha, NE, USA.
¹⁷ Good Samaritan Regional Medical Center Pharmacy, Samaritan Health Services, Corvallis, OR, USA.
¹⁸ EMD Serono Research and Development Institute, Inc, Billerica, MA, USA.
¹⁹ ISoP, Pharmacometrics Data Programming SIG, NJ, Bridgewater, USA.
²⁰ Merck & Co., Inc., Rahway, NJ, USA.

PMID: 39825146
DOI: 10.1007/s10928-024-09960-5

Editorial

Stronger together: a cross-SIG perspective on improving drug development

Luke Fostvedt et al. J Pharmacokinet Pharmacodyn. 2025.

. 2025 Jan 17;52(1):14.

doi: 10.1007/s10928-024-09960-5.

Authors

Affiliations

¹ ISoP, Statistics and Pharmacometrics SIG, NJ, Bridgewater, USA. luke.fostvedt@pfizer.com.
² Pharmacometrics and Systems Pharmacology, Pfizer Inc, Groton, CT, USA. luke.fostvedt@pfizer.com.
³ ISoP, Mathematical and Computational Sciences SIG, NJ, Bridgewater, USA. jiawei.zhou@pfizer.com.
⁴ Pharmacometrics and Systems Pharmacology, Pfizer Inc, Groton, CT, USA. jiawei.zhou@pfizer.com.
⁵ ISoP, Quantitative Systems Pharmacology SIG, NJ, Bridgewater, USA.
⁶ Clinical Pharmacology and Pharmacometrics, Bristol-Myers Squibb, Princeton, NJ, USA.
⁷ Biomedical Engineering Department, Rutgers University, Piscataway, NJ, USA.
⁸ ISoP, Mathematical and Computational Sciences SIG, NJ, Bridgewater, USA.
⁹ Department of Pharmacology and Systems Physiology, College of Medicine, University of Cincinnati, Cincinnati, OH, USA.
¹⁰ Translational PKPD, Johnson & Johnson Innovative Medicine, Spring House, PA, USA.
¹¹ ISoP, Clinical Pharmacometrics SIG, NJ, Bridgewater, USA.
¹² PD-value B.V, Utrecht, Netherlands.
¹³ ISoP, Statistics and Pharmacometrics SIG, NJ, Bridgewater, USA.
¹⁴ Clinical Pharmacology Modeling & Simulation, Genentech, South San Francisco, CA, USA.
¹⁵ Laboratory for Systems Medicine, College of Medicine, University of Florida, Gainesville, FL, USA.
¹⁶ Antiviral Pharmacology Laboratory, College of Pharmacy, University of Nebraska Medical Center, Omaha, NE, USA.
¹⁷ Good Samaritan Regional Medical Center Pharmacy, Samaritan Health Services, Corvallis, OR, USA.
¹⁸ EMD Serono Research and Development Institute, Inc, Billerica, MA, USA.
¹⁹ ISoP, Pharmacometrics Data Programming SIG, NJ, Bridgewater, USA.
²⁰ Merck & Co., Inc., Rahway, NJ, USA.

PMID: 39825146
DOI: 10.1007/s10928-024-09960-5

No abstract available

PubMed Disclaimer

Conflict of interest statement

Declarations. Competing interests: Luke Fostvedt is an employee of Pfizer and owns stock in Pfizer.Jiawei Zhou is an employee of Pfizer and owns stock in Pfizer.Anna Kondic is an employee of BMS and owns stock in BMS.Meghan Pryor is an employee of Johnson & Johnson and owns stock in J&J.Luning Zhuang is an employee of BMS and owns stock in BMS.Jeroen Elassaiss-Schaap is the owner of PD-value B.V.Phyllis Chan is an employee of Genentech and owns stock in Roche.Kosalaram Goteti is an employee of EMD Serono.Neelima Thanneer is an employee of BMS.Jing Su is an employee of Merck & Co and owns stock in Merck.Sihem Ait-Oudhia is an employee of Merck & Co and owns stock in Merck.

References

1. International Society of Pharmacometrics (ISoP) Website (2024) https://www.isop.org/home . Accessed August 2, 2024
1. Madabushi R, Seo P, Zhao L, Tegenge M, Zhu H (2022) Role of model-informed drug development approaches in the lifecycle of drug development and regulatory decision-making. Pharm Res 39(8):1669–1680. https://doi.org/10.1007/s11095-022-03288-w - DOI - PubMed - PMC
1. Moore H (2019) The mathematical and computational sciences special interest group of the International Society of Pharmacometrics. CPT: Pharmacometrics & Systems Pharmacology 8 (7):433. https://doi.org/10.1002/psp4.12410
1. Joshi A, Ramanujan S, Jin JY (2023) The convergence of pharmacometrics and quantitative systems pharmacology in pharmaceutical research and development. Eur J Pharm Sci 182:106380. https://doi.org/10.1016/j.ejps.2023.106380 - DOI - PubMed
1. Elassaiss-Schaap J, Rossenu S, Lindauer A, Kang S, De Greef R, Sachs J, De Alwis D (2017) Using model‐based learn and confirm to reveal the pharmacokinetics‐pharmacodynamics relationship of pembrolizumab in the KEYNOTE‐001 trial. CPT: Pharmacometrics Syst Pharmacol 6(1):21–28. https://doi.org/10.1002/psp4.12132 - PubMed

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Stronger together: a cross-SIG perspective on improving drug development

Affiliations

Stronger together: a cross-SIG perspective on improving drug development

Authors

Affiliations

Conflict of interest statement

References

Publication types

LinkOut - more resources

Full Text Sources